Regulatory Affairs Senior Manager CMC – Provide strategic leadership for EU & RoW Projects and grow to become a GRL

Reference: TM110619

Expiry Date: 11-10-2019

Categories R & D, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

RA Senior Manager CMC - Provide strategic leadership for EU & RoW Projects and grow to become a GRL

Location: Brussels

My client is a highly rated and extremely successful Pharmaceutical company with very good benefits and a culture driven by patient value creation. They have developed a dynamic and multi-cultural working environment that nurtures autonomy and creative thinking and provides opportunities for individuals to excel in a collaborative, team-based environment. This entrepreneurial mind-set fosters diverse perspectives and drives their passion for impact within the sector.

We are leading the recruitment campaign to find a strong and experienced Regulatory Affairs (Snr) Manager with significant strategic acumen, as well as stakeholder intelligence, for an EU and RoW role that will grow into a global position.

The successful candidate will not only have technically strong CMC expertise/experience but also be able to demonstrate the ability to swiftly build credibility and engagement amongst the team and for broad range of stakeholders across all high value markets.

Salary and Package

My client company offers a very competitive basic salary plus good bonus levels along with a highly rated benefits package and full flexibility around working from home 1-2 day3 days a week.  You will also receive a long-term career plan focused on both technical and managerial skills and goals.

You will also take responsibility for the following CMC focused challenges:

  • Represent Regulatory CMC at EU and Global meetings with a focus on bringing technical expertise, creativity and innovation as you maximize the business benefits balanced with regulatory compliance.
  • Co-ordinate and drive global regulatory strategy for complex submissions and determine and drives the execution of regional CMC regulatory plans in line with the global regulatory strategy.
  • Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the development life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Regulatory CMC
  • Initiate and lead regional Health Authority interactions and negotiations as appropriate
    Provide leadership within the department through specialized matrix functions and by utilizing CMC regulatory expertise to drive improvements.

Experience needed:

  • Ideally you will have 4-10 years in Regulatory Affairs CMC in EU and/or International markets
  • Knowledge of HA negotiation
  • Project/portfolio management experience
  • Strong leadership, negotiation and communication skills.

 

To Apply!

To apply for this role, please  contact Theo Moore or Oli Dimitrov on +44 20 7801 3384, or send your full CV in confidence to cv@advtalent.com.

 

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